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Information available on the risks of neurodevelopmental disorders (NDs) associated with in utero exposure to valproate (VPA) and to other antiepileptic drugs (AEDs) is limited. A nationwide population-based cohort study was conducted based on comprehensive data of the French National Health Data System (SNDS). Liveborn infants without brain malformation, born between January 2011 and December 2014, were followed from birth up to December 2016. NDs were identified based on diagnoses of mental or behavioural disorders and utilization of speech therapy, orthoptic or psychiatric services. The risk of NDs was compared between children exposed in utero to AED monotherapy and unexposed children, using Cox proportional hazard models adjusted for maternal and neonatal characteristics. The cohort included 1,721,990 children, 8848 of whom were exposed in utero to AED monotherapy. During a mean follow-up of 3.6 years, 15,458 children had a diagnosis of mental or behavioural disorder. In utero exposure to VPA was associated with an increased risk of NDs overall (aHR: 3.7; 95% CI 2.8–4.9) and among children born to a mother without mental illness (aHR 5.1; 95% CI 3.6–7.3). A dose–response relationship was demonstrated and the risk of NDs was more particularly increased for an exposure to VPA during the second or third trimesters of pregnancy. Among the other AEDs, only pregabalin was consistently associated with an increased risk of NDs (aHR: 1.5; 95% CI 1.0–2.1). This study confirms a four to fivefold increased risk of early NDs associated with exposure to VPA during pregnancy. The risk associated with other AEDs appears much lower.

The aims were to review practices concerning Differential Item Functioning (DIF) detection in composite measurement scales, particularly those used in health research, and to provide guidance on how to proceed if statistically significant DIF is detected. This work specifically addressed the Rasch model which is the subject of growing interest in the field of health owing to its particularly advantageous properties. There were three steps: 1) Literature review to describe current practices; 2) Simulation study to determine under which conditions encountered in health research studies can erroneous conclusions be drawn from group comparisons when a scale is affected by DIF but which is not considered; 3) Based on steps 1 and 2, formulation of recommendations that were subsequently reviewed by leading internationally recognized experts. Four key recommendations were formulated to help researchers to determine whether statistically significant DIF is meaningful in practice, according to the kind of DIF (uniform or non-uniform) and the DIF effect size. This work provides the first recommendations on how to deal in practice with the presence of DIF in composite measurement scales used in health research studies.

Background The Patient Reported Outcome Measurement Information System profile instruments include “high information” items drawn from large item banks following the application of modern psychometric criteria. The shortest adult profile, PROMIS-29, looks set to replace existing short-form instruments in research and clinical practice. The objective of this study was to undertake the first psychometric evaluation of the Norwegian PROMIS-29, following a postal survey of a random sample of 12,790 Norwegians identified through the National Registry of the Norwegian Tax Administration. Confirmatory factor analysis was used to assess structural validity. Fit to the Rasch partial credit model and differential item functioning (DIF) were assessed in relation to age, gender, and education. PROMIS-29 scores were compared to those for the EQ-5D-5L and the Self-assessed Comorbidity Questionnaire (SCQ), for purposes of assessing validity based on a priori hypotheses. Results There were 3200 (25.9%) respondents with a mean age (SD) of 51 (20.7, range 18 to 97 years) and 55% were female. The PROMIS-29 showed satisfactory structural validity and acceptable fit to Rasch model including unidimensionality, and measurement invariance across age and education levels. One pain interference item had uniform DIF for gender but splitting gave satisfactory fit. Domain reliability estimates ranged from 0.85 to 0.95. Correlations between PROMIS-29 domain, SCQ and EQ-5D scores were largely as expected, the largest being for scores assessing very similar aspects of health. Conclusions The Norwegian version of the PROMIS-29 is a reliable and valid generic self-reported measure of health in the Norwegian general population. The instrument is recommended for further application, but the analysis should be replicated and responsiveness to change assessed in future studies before it can be recommended for clinical and health services evaluation in Norway.

To estimate the systemic serious adverse event (SAE) rates after colonoscopy and to identify their risk factors. A nationwide cohort study was conducted using the comprehensive French claims databases SNDS (National Health Data System). Patients aged 30 years and over who underwent a first screening or diagnostic colonoscopy in 2010-2015 were included. The rates of cardiovascular and renal SAEs were estimated within 5 days after colonoscopy. The standardized incidence ratios were calculated to compare these incidence rates with those of the same events in the general population, and the associated risk factors were assessed by multilevel logistic regression. Among the 4,088,799 included patients (median age, 59 years [interquartile range = 50-67]; 55.2% women; 30.1% with a Charlson index score ≤1), the 5-day SAE incidence rate was 2.8/10,000 procedures for shock, 0.87/10,000 for myocardial infarction, 1.9/10,000 for stroke, 2.9/10,000 for pulmonary embolism, 5.5/10,000 for acute renal failure, and 3.3/10,000 for urolithiasis. These SAEs occurred 3.3 to 15.8 times more often during the first 5 days after colonoscopy than expected in the general population. Thirty-day mortality rates ranged from 2.2/1,000 cases of urolithiasis to 268.1/1,000 cases of shock. Increasing age was associated with an increasing incidence of SAEs. Risks of shock and acute renal failure were associated with a greater number of comorbidities than the other SAEs. Colonoscopies in university hospitals were associated with higher risks, reflecting patient selection processes. The systemic SAEs can be associated with a substantial mortality. They should be taken into account when deciding colonoscopy, in addition to perforation and bleeding, particularly in elderly patients with multiple comorbidities.

ObjectiveOur primary objective was to estimate an updated prevalence of SLE in France in 2020. We also explore the sociodemographic characteristics of patients with SLE, the social and spatial variability and also study and use hydroxychloroquine prescription patterns as an external validation for case ascertainment.MethodsWe used the French national health data system, which covers almost all of the 67 million people living in France. Prevalent cases were identified among inpatients and people granted a long-term disease status, using the International Classification of Diseases, 10th Revision code for SLE. Filled prescriptions of hydroxychloroquine were also counted.ResultsIn 2020, we identified 54 804 patients with SLE; this corresponds to an overall prevalence of 81.6 per 100 000 people. The prevalence estimates were 137.0 per 100 000 in women and 22.5 per 100 000 in men. The highest standardised prevalences were observed in the French overseas departments and in the mainland departments to which people from these departments frequently migrate. Unexpectedly, we did not find an association between the prevalence of SLE in mainland France and a social deprivation index. A prescription of hydroxychloroquine was filled at least once for 67.7% of the patients overall and reached 86.7% of those aged between 20 and 24.ConclusionsOur study provides recent, accurate estimates of the prevalence and social and geographical distribution of SLE in France. We observed an almost twofold increase in prevalence, relative to a previous estimate (from 2010) based on the same database. The high proportion of patients receiving a prescription of hydroxychloroquine is in line with current treatment guidelines.

To review current practice and update guidelines for the methodology of shortening composite measurement scales (CMSs). A literature review gathered data on 91 shortening processes from 1995 to 2009. The validity of the initial CMS, the shortening methods, and the validity of the derived short-form scales were examined. The results were compared with those from a previous literature review (articles from 1985 to 1995) to develop updated guidelines for CMS shortening. The literature review revealed a persisting lack of use of rigorous methodology for CMS shortening. Of the 91 cases of CMS shortening, 36 combined a content approach and a statistical approach; 45 used only a statistical approach and 10 (11%) only a content approach. The updated guidelines deal with the validity and conceptual model of the initial CMS, the preservation of content and psychometric properties during shortening, the selection of items, and the validation of the short form. Item reduction based on a rigorous methodology is necessary if the short-form instrument aims to maintain the validity and other measurement properties of the parent instrument, which in turn supports application in research and clinical practice.

Women with hormone-dependent breast cancer are treated with aromatase inhibitors (AI) to slow disease progression by decreasing estrogen levels. However, AI have adverse effects, including pain, with potentially serious impact on quality of life (QOL) and treatment compliance. We evaluated quality of life during the first year of AI treatment, focusing particularly on the impact of pain. In a multicenter cohort study of 135 women with early-stage breast cancer, free of pain at the initiation of AI treatment, quality of life (by the EORTC QLQ-BR23), somatic and psychic symptoms, psychological characters, temperament and coping strategies were assessed at baseline and at each follow-up visit (1, 3, 6 and 12 months). The impact of treatment-induced pain on quality of life during follow-up was determined with repeated-measures regression models. These models were constructed to assess the effects of pain and pain type on quality of life during follow-up, taking into account predictors associated with quality of life at baseline. Prior ganglion resection, taxane treatment and chemotherapy, a high amplification score on the pain catastrophizing scale, and a high harm avoidance score on the personality questionnaire were associated with a significantly lower baseline QOL. Fifty-seven percent of women developed pain of five different types: upper or lower limb joint pain, diffuse pain, neuropathic pain, tendon pain and mixed pain. A significant decrease in QOL was noted in the women with pain, particularly for body image, sexual functioning and future perspectives. Moreover, the impact of pain on QOL depended on the type of pain experienced. In conclusion, women treated with aromatase inhibitors display changes in quality of life and the degree of change in quality of life depends mostly on the type of pain experienced. Oncologists and patients should be aware of painful adverse effects of AI and encouraged to provide or receive earlier and more appropriate management of these effects.

IntroductionAlthough the working population carries the greatest burden of long COVID, occupational and non-occupational factors of the condition have not yet been well documented in this population. The aim of this study was to investigate these factors.MethodsA nationwide random sampling cross-sectional survey was conducted among the adult population in mainland France after the large Omicron waves in the autumn of 2022. Post-COVID-19 condition (PCC) was defined according to the WHO. Associations of occupational and non-occupational factors with PCC were tested in a conceptual model accounting for the relationships between these factors and considering two control groups (previously infected participants without PCC and participants with no reported or diagnosed SARS-CoV-2 infection). Interactions between occupational and non-occupational factors were considered.ResultsThe survey included 1131 working adults. PCC was positively associated with reported infection while providing care (prevalence ratio (PR)=2.06 (95% CI 1.08 to 3.94)), being in contact with a colleague (PR=1.61 (95% CI 1.04 to 2.48)) and increased workload (PR=2.85 (95% CI 1.12 to 7.24)), whereas it was negatively associated with reported infection while being in contact with the public or clients (PR=0.23 (95% CI 0.07 to 0.76)). Several non-occupational factors were associated with PCC: sex, household size, household financial satisfaction, number of pre-existing chronic conditions, anxiety, injury sequelae and perceived SARS-CoV-2 infection severity. No interactions were found between these factors.ConclusionsReducing the burden of long COVID in the working population requires public health strategies that consider a wide spectrum of factors, including work conditions in a broad sense. Specific attention should be given to the most vulnerable workers accumulating such factors.

Background To assess the associations between anxiety and depressive symptoms and post-COVID-19 condition (PCC) by exploring the direction of these associations and their relevance in the definition of PCC.Methods: Nationwide survey among French adults, recruited between March and April, 2022, using a quota method to capture a representative sample of the general population with regard to sex, age, socioeconomic status, size of the place of residence, and region. We included all participants who met the World Health Organization (WHO) definition of PCC in addition to a random sample of participants infected with SARS-COV-2 for at least 3 months but without PCC. Self-reported anxiety and depressive symptoms, chronic anxiety and depression (for more than 3 years), and anxiety and depression were measured using the GAD-2 and PHQ-2 questionnaires, respectively.Results: In a sample of 1,095 participants with PCC and 1,021 participants infected with SARS-COV-2 without PCC, 21% had self-reported anxiety and 18% self-reported depression, whereas 33% and 20% had current measured symptoms of anxiety and depression, respectively. The high prevalence of these symptoms cannot only be explained by the characterization of PCC, as only 13.4% of anxiety symptoms and 7.6% of depressive symptoms met the WHO criteria for PCC. Only one participant met the WHO criteria based on self-reported anxiety or depressive symptoms alone, as these were always combined with other symptoms in patients with PCC. Chronic symptoms were associated with PCC (aOR 1.27; 95% CI: 1.00–1.61). In addition, measured anxiety was associated with PCC (aOR = 1.29; 95% CI: 1.02–1.62).Conclusions: Pre-COVID-19 chronic anxiety and depression may play a role in the development of PCC or share vulnerability factors with it. Our results challenge the inclusion of anxiety and depression in the definition of PCC.

Robust public health and health system response to the increasing burden of multimorbidity worldwide requires detailed epidemiological examination of its key sociodemographic and geographic determinants. We investigated the role of gender, age and socioeconomic and geographic factors on multimorbidity (i.e., having two or more conditions) in the adult population in France and examined implications for surveillance and prevention. We used data from two large nationwide representative surveys with cross-sectional and longitudinal health and socio-demographic indicators, conducted in France between 2008 and 2014. Morbidity counts and frequent dyads/triads of conditions independently impacting mortality, activity limitations, and perceived health were investigated with regard to differences in gender, age, socioeconomic (education, occupation and income) and geography (size of the urban unit and region). The component conditions of multimorbidity varied with gender and age. Women experienced multimorbidity 23-31% more frequently and at a younger age (5-15 years earlier) than men. Multimorbidity increased with age while its associations with most health indicators weakened with it. Multimorbidity was strongly and independently associated with socioeconomic indicators, with a strong inverse dose-response relationship with education, but less consistently with geographic factors. Multimorbidity has diverse and variable components and impacts across gender and age. It is strongly associated with socioeconomic factors, notably educational level, for which causality appears likely. Consideration of this diversity and variability, its common occurrence in dyads and triads, and its impact on health outcomes according to age and gender may contribute to efficient surveillance and support the identification of prevention strategies targeting middle-aged men and women.